The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD

The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD). 

More specifically, the specifies aspects like sample sizes, acceptance criteria and other critical points for the device performance evaluation.

In this context, the guidance document differentiates between first line assays, confirmatory/ supplementary assays and other categories. Furthermore, MDCG 2021-21 emphasizes the importance of the state of the art.
It states that the performance evaluation should be carried out in direct comparison to a CE marked state of the art test. In addition, performance evaluations should be conducted on a population that is equivalent to the European population. 

Further direction is provided on considerations regarding sensitivity/ specificity, interference/ cross reactivity and batch testing.

Manufacturers are requested to carefully review the document and make sure that the corresponding requirements are fulfilled. If not fulfilled, validation related to the performance evaluation should be corrected as soon as possible. Competent authorities may conduct technical documentation audits and require product de-registrations if the requirements have not been met.

MDCG 2021-21 also says that “the content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months.”

So the guidance is crucial also for fulfilling the coming IVDR requirements, which will become applicable as of May 26, 2022.

Please let us know should you wish mdi Europa to provide you with the guidance document.

Source: European Commission

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